Manager, Reagent QC

Tempus · Raleigh-Durham, NC

Company

Tempus

Location

Raleigh-Durham, NC

Type

Full Time

Job Description

Passionate about making a difference in the world of cancer genomics?

With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings. We are looking for a Manager who will be responsible for managing the daily reagent lab quality operations at all three Tempus Laboratory Sites.


What you’ll do:

  • Manage reagent quality control operations at all three lab sites to support lab testing, including but not limited to reagent testing, positive control monitoring, planning reagent making/aliquoting, and setting testing criteria for new reagents.
  • Lead team of supervisors, individual contributors, and mentor junior staff.
  • Track control performance trends and investigate incidents.  
  • Review daily, weekly, and monthly QC results and determine the validity of results, perform follow up as needed.
  • Troubleshoots and ensures corrective actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
  • Participate in internal and external audits as subject matter expert for QC workflows.
  • Collaborate with Supply Chain and Lab teams to ensure adequate supply of qualified reagents are available for clinical lab processing. 
  • Coordinate workflows with clinical lab operations, supply chain, bioinformatics, and quality assurance.
  • Ensure that all new lots and shipments of reagents are qualified and appropriately labeled for clinical lab processing.
  • Maintain reagent qualification records and manage quality control of reagent inventory.
  • Serve as an administrator within QMS modules (Medialab) utilized by the QC team.
  • Provide technical direction and guidance to laboratory employees.
  • Ensure laboratory practices meet CAP/CLIA/NYSDOH requirements.
  • Oversee safety within the laboratory and ensure all safety protocols are followed. Including the appropriate disposal of excess or expired reagents.  
  • Monitor reagent storage conditions and instigate investigations in response to any temperature excursions.  

Qualifications:

  • MS or BS in medical technology, clinical laboratory science, chemical, physical or biological science and at least 7 years of experience
  • Experience supervising others in a CLIA/CAP high-complexity laboratory
  • Experience with Next-Generation sequencing and molecular testing methods highly desired
  • Excellent communication skills
  • Thrive in a fast-paced environment
  • Ability to work with others to plan and carry out scientific programs
  • Self-driven and works well in an interdisciplinary team with minimal direction
  • Strong desire to build products that will save lives and change the course of cancer
  • Impeccable attention to detail
  • Able to travel to each lab site on a quarterly basis


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Date Posted

10/20/2022

Views

17

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